Adverse Events with Biomedicines

This book gathers definitions, classification, and major features of drugs related to AEs observed in pre- and post-licensing trials and studies. Covers drug efficacy, etiopathogenesis and immunogenicity, systemic acute syndromes and off-label treatments.

This monograph gathers and evaluates data on adverse events (AEs) associated specifically with those biomedicines monoclonal antibodies, fusion proteins, and cytokines that have recently entered therapeutic use in humans. All AEs observed when using each member of this new drug class are covered, with a view to improving understanding of pathogenesis, facilitating prevention, monitoring, and control, and contributing to the development of better drugs that provide benefits while minimizing risk. Further aspects here examined include the role of drug mechanisms of action and immunogenicity in relation to AEs outcome and induction of systemic syndromes. Additional data on AEs in off-label treatments are also considered.Electronic data sheets, downloadable from Springer Extra Materials platform, include more detailed safety data as well as additional basic information on product characteristics, pre- and post-marketing AEs classified according to frequency, and system/organ targeting. Data on excipients and selected information on drug interactions and associations are also provided. Adverse Events with Biomedicines: Prevention Through Understanding will serve as a detailed, practical guideline to this important new area, which demands the attention of clinicians, immunologists, oncologists, allergologists, public health professionals, and drug companies.

Synthetic and unique publication on adverse events of a new and fast-growing class of medicines Multidisciplinary interest (biomedical, public health, biologics producers for human therapy) Downloadable data sheets enclosed for rapid multi-entry search and consultation? Includes supplementary material: sn.pub/extras

Autorentext

Giuseppe Tridente is currently Professor Emeritus of Immunology at the University of Verona, where he was Dean of the Medical Faculty, founder of the Institute of Immunological Sciences, and Director of the Department of Pathology. In 1992 he founded and directed the Green Channel Veneto Regional Centre of Surveillance on Adverse Events to Vaccines. His research, mainly devoted to immunopathology, include experimental oncology, tumor immunology, histocompatibility and transplantation, pathophysiology of the thymus, HIV, and adverse events following immunization. He has 146 publications listed on MEDLINE and is also the author of the first Italian textbook on immunology and immunopathology (1979).

Inhalt

Part I General Aspects: 1 Introduction.- 2 Adverse drug events to biomedicines.- 3 Systemic syndromes caused by biomedicines.- Part II Monoclonal antibodies: 4 Monoclonal antibodies.- 5 Abciximab.- 6 Adalimumab.- 7 Alemtuzumab.- 8 Basiliximab.- 9 Belimumab.- 10 Bevacizumab.- 11 Brentuximab.- 12 Canakinumab.- 13 Catumaxomab.- 14. Certolizumab.- 15 Cetuximab.- 16 Daclizumab.-17 Denosumab.- 18 Eculizumab.- 19 Edrecolomab.- 20 Efalizumab.- 21 Gemtuzumab.- 22 Golimumab.- 23 Ibritumomab.- 24 Infliximab.- 25 Ipilimumab.- 26 Muromonab.- 27 Natalizumab.- 28 Nimotuzumab.- 29 Ofatumumab.- 30 Omalizumab.- 31 Palivizumab.- 32 Panitumumab.- 33 Pertuzumab.- 34Ranibizumab.- 35 Rituximab.- 36 Tocilizumab.- 37 Tositumomab.- 38 Trastuzumab.- 39 Ustekinumab.- Part III Fusion proteins: 40 Fusion proteins.- 41 Abatacept.- 42 Aflibercept.- 43 Alefacept.- 44 Belatacept.- 45 Etanercept.- 46 Rilonacept.- 47 Romiplostim.- Part IV Cytokines : 48 Cytokines.- 49 Interleukins.- 50 Denileukin-diftitox.-51 Anakinra.- 52 Interferons.- 53 Hemopoietic stimulatory factors.- 54 Myelopoietic stimulatory factors.- 55 Thrombopoietic stimulatory factor.- 56 Pluripotent growth factors.- 57 Epidermal growth factors.- Part V Overview: 58 Biomedicines as adverse event inducers.- 59 Conclusions and perspectives.